Eisai has been boosted by the news that regulators in Europe have given the green light to the Japanese drugmaker's antiepileptic Zonegran to be used as monotherapy.
Specifically, the European Medicines Agency has issued marketing authorisation approval to extend the use of once-daily Zonegran (zonisamide) from adjunctive therapy to also include monotherapy for the treatment of partial seizures in adults with newly-diagnosed epilepsy. The latest thumbs-up is based on a study of 583 patients, which compared zonisamide with twice-daily controlled release carbamazepine as monotherapy.
Zonegran demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy at six months, similar to controlled release carbamazepine and in the majority of patients this was achieved at the target dose of 300mg. The drug demonstrated non-inferiority to carbamazepine, was well tolerated and had no apparent safety concerns after one year at doses ranging from 300 to 500mg/day.
Commenting on the MAA, Michel Baulac, head of the epilepsy department at the Pitie-Salpetriere hospital in Paris, said that "monotherapy is the optimal treatment approach for managing epilepsy" so the approval is "of real significance" for newly-diagnosed patients who will, "for the first time, be able to access this proven treatment as a first-line option in their care pathway."
Zonegran is "already a successful once-daily, add-on therapy", noted Bettina Bauer, head of Eisai's epilepsy business unit in Europe, adding that the treatment is now one of only six drugs available as monotherapy. She added that "we will be working closely with health authorities and clinicians across Europe to ensure patients have access to this treatment from first diagnosis".